NCT01195688

Brief Summary

The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

June 2, 2011

Status Verified

June 1, 2011

Enrollment Period

3 months

First QC Date

September 3, 2010

Last Update Submit

June 1, 2011

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Safety of BI 638683 will be assessed in a descriptive way.

    up to 14 days post treatment

  • Tolerability of BI 638683 will be assessed in a descriptive way.

    up to 14 days post treatment

Secondary Outcomes (2)

  • To assess pharmacodynamics of BI 638683.

    up to 5 days post study drug administration

  • To assess pharmacokinetics of BI 638683.

    up to 5 days post study drug administration

Study Arms (2)

BI 638683

EXPERIMENTAL

1 single dose per subject as oral solution

Drug: BI 638683 or placebo

Placebo solution

PLACEBO COMPARATOR

1 single dose per subject as oral solution

Drug: Placebo solution

Interventions

BI 638683 or placeboDRUG

oral doses given to 6 subjects per dose group

BI 638683
Placebo solutionDRUG

oral doses given to 2 subjects per dose group

Placebo solution

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1279.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 6, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2010

Last Updated

June 2, 2011

Record last verified: 2011-06

Locations

DE(1)